CN107669984A - 一种用于治疗高血脂的组合物及其固体饮料和制备方法 - Google Patents
一种用于治疗高血脂的组合物及其固体饮料和制备方法 Download PDFInfo
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Abstract
本发明提供一种用于治疗高血脂的组合物及其固体饮料和制备方法。该组合物主要由余甘子、玉竹、姜黄、苦丁茶和白首乌等原料药按照不同的重量份数制备而成;该组合物对高血脂症具有很好的治疗效果。
Description
技术领域
本发明涉及中药领域,特别涉及一种用于治疗高血脂的组合物及其固体饮料和制备方法。
背景技术
高脂血症是指血脂水平过高,可直接引起一些严重危害人体健康的疾病,如动脉粥样硬化、冠心病、胰腺炎等,是一种常见病症,血脂是血液中所含类脂质的总称,血脂中主要包含胆固醇、甘油三脂、磷脂、脂肪酸等,在中老年人当中发病率高,它能够引起动脉粥样硬化,乃至冠心病、脑血栓、脑出血等,严重时会危及生命;因此,高脂血症的严重性绝对不能忽视,血脂过高的主要原因是进食含脂肪和胆固醇类食物过多,同时与遗传因素等有关系。
目前治疗高血脂的方式主要有药物治疗和手术治疗,手术治疗费用高且治疗效果不一,适用于极少数其他治疗方法无效的极难治的高胆固醇血症患者,治疗高血脂症的西药有非诺贝特、吉非罗齐、洛伐他丁等,但西药无法根治高脂血症,甚至对病情起到反作用,也有部分中药制剂用于治疗高血脂症,现有专利号CN104606404A公布了一种防治高血脂的中药组合物及其制备方法,该组合物由山楂、苦丁茶、远志等组成,该中药配方能够用于治疗高血脂症,但该组合物的制备方法是将所有药物粉碎,不能有效剔除杂质、将有效成分充分的提取出来,从而影响药效;专利号CN104474472A提供了具有降三高作用的苦丁茶含片及其生产方法,该含片使用了苦丁茶、罗汉果、玉竹、姜黄、长春花等10味中药原料,但其组方复杂,生产成本较高,因此急需一种高效长效的、组方简单的中药制剂,用于治疗高血脂症人群。
发明内容
为了解决现有技术中药效低、组方复杂等问题,本发明提供了一种用于治疗高血脂的组合物及其固体饮料和制备方法,该组合物疗效好、组方简单,可用于清热祛湿、生津润燥,标本兼调,是比较理想的降脂食品。
本发明具体技术方案如下:
本发明提供了一种治疗高血脂的组合物,该组合物主要由下列重量份的原料制备而成:
本发明通过大量的试验得出,采用以上原料药组成的组合物能够有效的治疗高血脂。
进一步的改进,组合物还包括重量份数为5-30的海底椰和10-20的海马干。
本发明在组合物中加入了上述2种原料药后,能够与各组分协同作用,进一步提高了组合物治疗高血脂的功效。
进一步的改进,该组合物由下列重量份的原料药制备而成:
进一步的改进,该组合物由如下方法制备而成:
1)将各材料按比例称量后,分别用水浸泡1-3h;
2)取浸泡后原料,用水煎煮3次,每次加水量为原料总重量的8-12倍,每次煎煮2-4h,过滤后合并滤液,取滤渣用滤渣2-3倍重量的75%乙醇回流提取2h,得煎液,然后将滤液与煎液合并,过滤,浓缩,干燥至粉末,即得所述组合物。
进一步的改进,该组合物的制备方法具体包括如下步骤:
a按照重量份数称取余甘子、玉竹和姜黄,用65%乙醇溶液加压煎煮3次,第一次加乙醇量为原料药总重的5倍,煎煮1h,第二次加乙醇量为原料药总重的4倍,煎煮1.5h,第三次加乙醇量为原料药总重的4倍,煎煮0.5h,合并各次滤液,过滤,浓缩,将浓缩液上大孔树脂吸附,用72%乙醇洗脱,将洗脱液浓缩干燥至粉末;
b按照重量份数称取组合物中剩余药物,放置于60℃烘箱中干燥30min,粉碎成1cm2,用水浸泡0.5h,用10倍量的水超声提取3h,过滤,残渣用6倍量的水回流提取3次,每次30min,合并各次滤液,浓缩,干燥至粉末;
c合并步骤a和步骤b获得的干燥粉末混合均匀,即得所述组合物。
通过以上方法制备的组合物可显著的提高各药物中有效成分的含量,使制备的组合物对高血脂具有更好的治疗效果。
为了服用方便并使药物达到更好的疗效,本发明将组合物和辅料制成颗粒剂,其中,组合物和辅料的重量份数比为1:2-5。
进一步的改进,辅料包括重量份数为2-5的失水山梨醇脂肪酸酯、1-10的聚氧乙烯单脂酸酯、2-5的聚乙烯吡咯烷酮和4-8的微晶纤维素。
本发明通过用失水山梨醇脂肪酸酯、聚氧乙烯单脂酸酯、聚乙烯吡咯烷酮和微晶纤维素作为辅料,可增强药物的溶化性,使药物能够在水中快速溶解。
为了便于服用,本发明将颗粒剂、甜味剂和水制备成固体饮料。
进一步的改进,颗粒剂、甜味剂和水的重量份数比为2:0.1-0.5:1-1.5。
其中,甜味剂可以是阿斯巴甜等任一水溶性甜味剂。
本发明通过在将组合物制备成固体饮料,可改善组合物的口感,增强患者的顺应性,且方便携带和运输,利于保存和储藏。
本发明提供的组合物可以制成用于治疗或辅助治疗高血脂的产品,对高血脂有显著的疗效,制备成固体饮料后,可加入水和甜味剂等进行冲调,口感甘、苦适宜,能够有效的降低患者体内的血脂含量,提高用药患者的生活质量。
具体实施方式
实施例1
一种组合物,该组合物由下列重量份的成分组成:
实施例2
一种组合物,该组合物由下列重量份的成分组成:
实施例3
一种组合物,该组合物由下列重量份的成分组成:
实施例4
一种组合物,该组合物由下列重量份的成分组成:
该组合物的制备方法为:
a按照重量份数称取余甘子、玉竹和姜黄,用65%乙醇溶液加压煎煮3次,第一次加乙醇量为原料药总重的5倍,煎煮1h,第二次加乙醇量为原料药总重的4倍,煎煮1.5h,第三次加乙醇量为原料药总重的4倍,煎煮0.5h,合并各次滤液,过滤,浓缩,将浓缩液上大孔树脂吸附,用72%乙醇洗脱,将洗脱液浓缩干燥至粉末;
b按照重量份数称取组合物中剩余药物,放置于60℃烘箱中干燥30min,粉碎成1cm2,用水浸泡0.5h,用10倍量的水超声提取3h,过滤,残渣用6倍量的水回流提取3次,每次30min,合并各次滤液,浓缩,干燥至粉末;
c合并步骤a和步骤b获得的干燥粉末混合均匀,即得所述组合物。
实施例5
一种组合物,该组合物由下列重量份的成分组成:
实施例6
一种组合物,该组合物由下列重量份的成分组成:
实施例7
一种组合物,该组合物由下列重量份的成分组成:
实施例8
一种组合物,该组合物由下列重量份的成分组成:
该组合物的制备方法为:
a按照重量份数称取余甘子、玉竹和姜黄,用65%乙醇溶液加压煎煮3次,第一次加乙醇量为原料药总重的5倍,煎煮1h,第二次加乙醇量为原料药总重的4倍,煎煮1.5h,第三次加乙醇量为原料药总重的4倍,煎煮0.5h,合并各次滤液,过滤,浓缩,将浓缩液上大孔树脂吸附,用72%乙醇洗脱,将洗脱液浓缩干燥至粉末;
b按照重量份数称取组合物中剩余药物,放置于60℃烘箱中干燥30min,粉碎成1cm2,用水浸泡0.5h,用10倍量的水超声提取3h,过滤,残渣用6倍量的水回流提取3次,每次30min,合并各次滤液,浓缩,干燥至粉末;
c合并步骤a和步骤b获得的干燥粉末混合均匀,即得所述组合物。
实施例9颗粒剂
颗粒剂由以下重量份的成分组成:
实施例10颗粒剂
颗粒剂由以下重量份的成分组成:
实施例11颗粒剂
颗粒剂由以下重量份的成分组成:
对照例1
一种组合物,与实施例2的区别之处在于,增加了重量份数为5的麦冬。
对照例2
一种组合物,与实施例2的区别之处在于,用川芎替代了姜黄。
对照例3
一种组合物,与实施例2的区别之处在于,删除了白首乌。
对照例4
一种组合物,与实施例6的区别之处在于,增加了重量份数为10的连翘。
对照例5
一种组合物,与实施例6的区别之处在于,用独活替代了海底椰。
对照例6
一种组合物,与实施例6的区别之处在于,删除了海马干。
对照例7颗粒剂
一种颗粒剂,与实施例10的区别之处在于,增加了2.5份的甘露醇。
对照例8颗粒剂
一种颗粒剂,与实施例10的区别之处在于,用吐温-80替代了聚乙烯吡咯烷酮。
对照例9颗粒剂
一种颗粒剂,与实施例10的区别之处在于,删除了聚氧乙烯单脂酸酯。
试验例1效果比较
1.高血脂动物模型:
SD大鼠,适应性饲养一周后,随机分为模型对照组、正常组、试验1组、试验2组、试验例3组、试验例4组、对照1组、对照2组、对照组3、对照例4和阳性对照组;试验1组使用本发明实施例2的组合物,试验2组使用本发明实施例4的组合物,试验3组使用本发明实施例5的组合物,试验4组使用本发明实施例6的组合物,实施例5组使用本发明实施例7的组合物,实施例6组使用本发明实施例8的组合物,对照1组使用对照例2的组合物,对照2组使用对照例4的组合物,对照3组使用对照例5的组合物,对照4组使用对照例6的组合物;每组6只,试验组和对照组的给药剂量为0.85g.kg-1.d-1,正常组与模型组给予等体积的生理盐水,共给药12周。
2.血脂含量的测定
各组动物于实验第0周和第12周周4上午9:00眼眶取血,分离血浆后测定血浆总甘油三酯、总胆固醇、低密度脂蛋白胆固醇水平,结果见表1。
表1各组合物对高血脂的治疗效果
3.结论
由表1可知,本发明实施例2、实施例4-8提供的组合物对小鼠的高血脂具有显著的治疗效果,且好于对照例2、对照例4-6组合物对高血脂症的治疗效果,证明本发明提供的组合物对高血脂具有很好的疗效,当本发明提供的组合物中的原料药减少或者被替换成别的原料药后,该组合物对高血脂的治疗效果显著降低,而实施例8的疗效好于
实施例6,证明本发明提供的组合物的制备方法对组合物的提取效率更高,对高血脂的治疗效果更好。
试验例2溶化性试验
取实施例9-11和对照例7-9的颗粒剂10g,加热水200ml,搅拌并观察颗粒剂完全溶化的时间,结果见表2;
表2溶化性试验结果
2015年版《中国药典》中规定,5min内颗粒剂应全部溶化或轻微浑浊,从表中可看出,加入本发明提供的失水山梨醇脂肪酸酯、聚氧乙烯单脂酸酯、聚乙烯吡咯烷酮和微晶纤维素后,所有的颗粒剂均在3min内溶化,极大的提高了颗粒剂的溶化性,缩短其溶化时间,进而可以更加快速和甜味剂溶解于水中形成液体饮料。
Claims (9)
1.一种用于治疗高血脂的组合物,其特征在于,所述组合物主要由下列重量份的原料制备而成:
2.如权利要求1所述的用于治疗高血脂的组合物,其特征在于,所述组合物还包括重量份数为5-30的海底椰和10-20的海马干。
3.如权利要求1所述的用于治疗高血脂的组合物,其特征在于,所述组合物由下列重量份的原料制备而成:
4.如权利要求1所述的用于治疗高血脂的组合物,其特征在于,所述组合物由如下方法制备而成:
1)将各材料按比例称量后,分别用水浸泡1-3h;
2)取浸泡后原料,用水煎煮3次,每次加水量为原料总重量的8-12倍,每次煎煮2-4h,过滤后合并滤液,取滤渣用滤渣2-3倍重量的75%乙醇回流提取2h,得煎液,然后将滤液与煎液合并,过滤,浓缩,干燥至粉末,即得所述组合物。
5.一种如权利要求1所述用于治疗高血脂的组合物的制备方法,其特征在于,所述制备方法具体包括如下步骤:
a按照重量份数称取余甘子、玉竹和姜黄,用65%乙醇溶液加压煎煮3次,第一次加乙醇量为原料药总重的5倍,煎煮1h,第二次加乙醇量为原料药总重的4倍,煎煮1.5h,第三次加乙醇量为原料药总重的4倍,煎煮0.5h,合并各次滤液,过滤,浓缩,将浓缩液上大孔树脂吸附,用72%乙醇洗脱,将洗脱液浓缩干燥至粉末;
b按照重量份数称取组合物中剩余药物,放置于60℃烘箱中干燥30min,粉碎成1cm2,用水浸泡0.5h,用10倍量的水超声提取3h,过滤,残渣用6倍量的水回流提取3次,每次30min,合并各次滤液,浓缩,干燥至粉末;
c合并步骤1)和步骤2)获得的干燥粉末混合均匀,即得所述组合物。
6.一种颗粒剂,其特征在于,所述颗粒剂包括权利要求1-3任一项所述的用于治疗高血脂的组合物和辅料,所述组合物和辅料的重量份数比为1:2-5。
7.如权利要求6所述的颗粒剂,其特征在于,所述辅料包括重量份数为2-5的失水山梨醇脂肪酸酯、1-10的聚氧乙烯单脂酸酯、2-5的聚乙烯吡咯烷酮和4-8的微晶纤维素。
8.一种固体饮料,包括权利要求6所述的颗粒剂、甜味剂和水,其特征在于,所述的颗粒剂、甜味剂和水的重量份数比为2:0.1-0.5:1-1.5。
9.权利要求1-3任一项所述的组合物在制备用于治疗或辅助治疗高血脂的产品中的应用。
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